Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)

Official title

Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)

Overview

The goal of this clinical trial is to evaluate the safety, feasibility, and preliminary clinical benefit of focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH) in adults with treatment-resistant moderate-to-severe substance use disorder (SUD). The main questions it aims to answer are: Can FUS neuromodulation be safely delivered to the nucleus accumbens (NAc) and/or anterior insula (aI)? Does FUS neuromodulation result in reduced substance use severity, as measured by Timeline Followback (TLFB), by 4 weeks post-treatment? Participants will: Complete baseline clinical assessments, questionnaires, imaging, and safety assessments. Undergo two MRI-guided FUS neuromodulation sessions approximately 4 weeks apart. Attend follow-up visits for safety monitoring, symptom assessments, quality-of-life measures, and additional imaging where applicable.

Detailed description

A total of 20 participants with treatment-resistant moderate-to-severe substance use disorder (SUD) will be enrolled and treated in this study. Participants will be enrolled from the local practices of the psychiatrists/addiction physicians involved in the study and through outside referrals, including physician referrals or self-referrals. Patient eligibility will be assessed at a screening appointment by the study coordinator and a physician associated with the study. The anticipated enrollment period is approximately two years.

Interventions

• Device Next Generation Dome Helmet (NGDH)
  Focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) system under MRI guidance. The device delivers low-intensity pulsed ultrasound to targeted brain regions, including the nucleus accumbens and anterior insula, to modulate neural activity. Participants will undergo two treatment sessions spaced four weeks apart. One session may include sham exposure in which the device is positioned identically but no therapeutic ultrasound energy is delivered.

Primary outcome measures

• Incidence and Severity of Adverse Events [Time frame: From baseline (prior to first treatment) through 4 weeks after the second treatment, including assessments on the day of each treatment, 1 day, 1 week, and 2 weeks after each treatment, and at 4 weeks after the second treatment.]

Secondary outcome measures (11)

• Change in Number of Drinking Days Using the Timeline Followback (TLFB) [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment]
• Change in Average Number of Drinks per Drinking Day Using TLFB [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment]
• Change in Percent Days Abstinent Using TLFB [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment]
• Change in Number of Heavy Drinking Days Using TLFB [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment]
• Subjective Ratings of Mood, Anxiety, Energy, and Optimism Using 1-9 Likert Scales [Time frame: Baseline, immediately before and after each treatment, 24 hours after each treatment, and 2 and 4 weeks after the second treatment]
• Change in Depressive Symptoms Using the Hamilton Depression Rating Scale (HAMD-17) [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment]
• Change in anxiety symptoms using the Beck Anxiety Inventory (BAI) [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment]
• Change in drug use severity using the Drug Use Disorders Identification Test (DUDIT) [Time frame: Baseline, 3 months after the second treatment, and 6 months after the second treatment]
• Barratt Impulsiveness Scale (BIS-11) [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment]
• DSM-5 substance use disorders symptom checklist [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment.]
• The Colorado Symptom Index (CSI) [Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment]

Eligibility criteria

Inclusion criteria

• Must be deemed to have capacity to provide informed consent (determined by the investigator)
• Age between 18 to 70 (inclusive)
• Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine/tobacco use disorder) in the moderate to severe range according to the DSM-5
• Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care
• On a stable regimen of their psychiatric medications for 30 days before enrolment.

Exclusion criteria

• Pregnant or intending to be pregnant during the study
• Known active seizure disorder, significant head injury with an imaging verified lesion
• Medical illness that is deemed to be unstable or may confound the effects of the intervention
• Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
• Unable to reliably attend the required screening, treatment, and follow up appointments.
• Severe claustrophobia, identified by the subject to be a limiting factor preventing MRI.
• Scores 18 or below on Montreal Cognitive Assessment (MoCA)
• Weighs 250 lbs or more.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Sunnybrook Health Sciences Centre — Toronto

Identifiers

NCT: NCT07684976 · 6703

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗